Abstract
Background:
Early postmenopause is characterized by persistent menopausal symptoms that may impair quality of life. Globally, early postmenopausal care is constrained by sociocultural barriers and limited availability of nurse-led, nonpharmacological services. Mindfulness-Based Stress Reduction (MBSR), aligned with holistic nursing philosophy, lacks evidence in culturally adapted, nurse-led, digitally supported formats for early postmenopausal women.
Purpose:
To evaluate the feasibility and acceptability of a nurse-led digitally supported MBSR program for early postmenopausal women on quality of life and holistic health indicators.
Methods:
A total of 128 early postmenopausal women from both rural and urban areas will be recruited for this community-based randomized waitlist-controlled trial. After screening and informed consent, participants will be randomized to an eight-week nurse-led MBSR intervention or a waitlist control group receiving routine care. The digitally delivered intervention includes mindfulness meditation, mindful breathing, gentle yoga, attention-based practices, and supervised daily practice. Menopause-related quality of life measured by the Menopause-Specific Quality of Life Questionnaire is the primary outcome; secondary outcomes include mindfulness, sexual function, and program acceptability. Assessments will occur at baseline and post-intervention, with weekly MENQOL tracking.
Conclusions:
This study is expected to provide evidence supporting feasible, holistic, nurse-led, nonpharmacological care for early postmenopausal women in the community settings.
Background of the Study
Menopause is defined as 12 consecutive months of amenorrhea not attributable to other medical causes and typically occurs between 45 and 55 years of age (World Health Organization [WHO], 2024). It represents a major biological transition associated with vasomotor, physical, psychosocial, and sexual symptoms that may interfere with daily functioning and reduce quality of life (Davis et al., 2015; Freeman & Sherif, 2007).
Early postmenopause, defined by the Stages of Reproductive Aging Workshop (STRAW+10) criteria as the first 5–8 years following the final menstrual period (stages +1a to +1c), represents a biologically distinct phase characterized by sustained hypoestrogenism and ongoing symptom burden (Harlow et al., 2012). During stages +1a and +1b (approximately the first 2 years), estradiol levels decline sharply, follicle-stimulating hormone levels rise and stabilize, and neuroendocrine adaptation remains incomplete. Although hormonal fluctuations are reduced compared with the perimenopausal transition, persistent estrogen deficiency may contribute to continued vasomotor symptoms, sleep disturbance, mood variability, fatigue, and sexual concerns. Stage +1c (approximately years 3–6) reflects hormonal stabilization; however, symptom burden may continue in a substantial proportion of women. Evidence suggests that vasomotor symptoms may persist for several years following the final menstrual period (Davis et al., 2015; Freeman & Sherif, 2007).
Emerging evidence also indicates that perceived stress may exacerbate vasomotor symptoms and psychosocial distress during the postmenopausal period through hypothalamic pituitary adrenal axis activation and altered thermoregulatory sensitivity. Therefore, interventions targeting stress regulation may influence both psychological and somatic symptom experience.
Although hormonal fluctuations stabilize during this stage, many women experience persistent vasomotor symptoms, sleep disturbances, mood changes, fatigue, and sexual concerns that collectively diminish menopause-specific quality of life (MENQOL) (Dalal & Agarwal, 2015; Nappi & Lachowsky, 2009).
The global population of postmenopausal women is increasing due to demographic ageing. In India, menopause occurs at a younger average age compared with global estimates (Ahuja, 2016; Prasad et al., 2021), potentially prolonging exposure to postmenopausal symptom burden. Sociocultural stigma and limited awareness may further restrict care-seeking behaviors, particularly in community settings where specialist menopausal services are limited (Roshini et al., 2025).
Although hormone therapy remains effective for vasomotor symptoms, its use may be limited by contraindications, perceived risks, access barriers, and patient preference (The North American Menopause Society, 2022). Consequently, non-pharmacological approaches, including behavioral and mind–body interventions, are increasingly recognized as complementary strategies for symptom management. Systematic reviews of yoga and other mind–body interventions have demonstrated modest benefits for menopausal symptom relief, highlighting the broader therapeutic potential of integrative approaches (Cramer et al., 2012).
Mindfulness-Based Stress Reduction (MBSR), originally developed by Kabat-Zinn (1990), is an eight-week structured program integrating mindfulness meditation, body awareness, and gentle movement practices. Meta-analytic evidence indicates that mindfulness-based interventions reduce perceived stress, anxiety, and psychological distress across diverse populations (Goyal et al., 2014). Evidence further suggests that greater engagement in mindfulness practice is associated with reductions in medical and psychological symptoms, supporting a potential dose–response relationship (Carmody & Baer, 2008). Among midlife and postmenopausal women, randomized trials have demonstrated reductions in vasomotor symptom bother and improvements in psychological well-being (Carmody et al., 2011; Yazdani Aliabadi et al., 2021). More recent randomized evidence also suggests that mindfulness-based interventions may improve menopause-related quality of life and psychological well-being, further supporting their relevance for this population (Amin et al., 2025). However, stage-specific trials focusing exclusively on early postmenopause remain limited, particularly with respect to multidimensional menopause-specific outcomes and sexual functioning.
In parallel, digital delivery models have expanded access to mindfulness programs. Yet many applications are self-guided and lack structured professional facilitation, which may influence adherence, engagement, and skill acquisition (Jongebloed et al., 2024). A nurse-led, synchronously delivered digital format may offer a balanced approach by combining real-time interaction with scalability and community accessibility.
Holistic nursing practice emphasizes integrated care addressing physical, emotional, and behavioral dimensions of health. Mindfulness-based interventions align with this framework by fostering emotional regulation, adaptive coping, and self-awareness. Within community settings, a culturally adapted, nurse-led digital MBSR model may enhance accessibility and acceptability, particularly for women who may be hesitant to seek specialist menopausal services.
Therefore, this randomized waitlist-controlled trial is designed to evaluate the effectiveness and feasibility of a culturally adapted, nurse-led, digitally supported MBSR program among early postmenopausal women in rural and urban communities. By focusing on a clearly defined reproductive stage and employing standardized multidimensional outcome measures, the study aims to generate stage-specific evidence to inform scalable, non-pharmacological approaches to menopausal care.
Rationale
Despite growing evidence supporting mindfulness-based interventions in midlife women, trials focusing exclusively on early postmenopause remain scarce. Furthermore, most digital mindfulness programs are self-guided and lack structured professional facilitation. A culturally adapted, nurse-led synchronous digital MBSR model may offer a scalable, contextually appropriate non-pharmacological strategy for community-based menopausal care.
This study is therefore distinct in four key ways: (1) it targets a clearly defined reproductive stage (STRAW+10 early postmenopause), (2) it integrates a standardized MBSR curriculum with nurse-led facilitation rather than automated delivery, (3) it combines digital accessibility with real-time interaction to enhance adherence and fidelity, and (4) it evaluates multidimensional menopause-specific outcomes using validated instruments within a randomized controlled framework. By addressing stage specificity, delivery model, and contextual adaptation simultaneously, the trial seeks to generate evidence that is both biologically grounded and implementation-relevant.
Objectives of the Study
Primary Objective
To evaluate the effectiveness of the nurse-led digitally supported MBSR program in improving MENQOL (MENQOL total score) among early postmenopausal women by:
comparing pre-post changes within the intervention group (baseline to week 8), and comparing post-intervention scores between the intervention and waitlist control groups using baseline-adjusted analyses.
Secondary objectives
To examine changes in:
psychosocial health (Mindful Attention and Awareness Scale (MAAS) scores) sexual function (Female Sexual Function Index (FSFI) scores) physical symptom domains (MENQOL subscales) through both within-group and between-group comparisons. To evaluate the feasibility and acceptability of a nurse-led digitally supported MBSR program using adherence rates and satisfaction scores. To explore associations between sociodemographic characteristics (age, education, residence, and time since menopause) and changes in key health outcomes. To establish the content validity of the culturally adapted NL-MBSR curriculum prior to trial implementation.
Setting of the Study and Recruitment Procedures
The study will be conducted in selected urban municipal wards and rural Gram Panchayat Units in Gangtok district, Sikkim, India. These areas are served by Urban Health Centers and Primary Health Sub-centers.
Recruitment Process: Recruitment will occur in three sequential stages.
Stage 1: Community Approach: Accredited Social Health Activists (ASHAs) and community health workers will identify potentially eligible women based on age and residence within selected clusters. Their role will be limited to introducing the study and inviting interested women to attend a community information meeting or schedule a home visit with the research team. ASHAs will not determine eligibility or collect research data. Stage 2: Preliminary Eligibility Screening: Prior to screening, verbal screening consent will be obtained to collect minimal demographic and menstrual history information solely for eligibility determination. A trained research assistant will conduct preliminary screening, including:
Age verification Menstrual history consistent with STRAW+10 early postmenopause criteria Review of exclusion criteria (hormone therapy use, prior hysterectomy/oophorectomy, prior structured mindfulness training, major medical or psychiatric illness, or current participation in structured stress-reduction programs) No outcome measures will be administered at this stage. Stage 3: Informed Consent and Baseline Assessment: Women meeting preliminary eligibility criteria will receive a detailed face-to-face explanation of the study from a trained research team member. A written Participant Information Sheet (available in English, Hindi, and Nepali) will be provided. Participants will be given adequate time to ask questions before providing written informed consent. Baseline outcome measures (MENQOL, MAAS, and FSFI) will be administered only after written informed consent is obtained.
Study Design
This study is a community-based randomized waitlist-controlled trial designed to evaluate the effectiveness of a Nurse-Led MBSR (NL-MBSR) program among early postmenopausal women. Selected urban wards and rural Gram Panchayat Units in Gangtok district will be identified using stratified random sampling.
A total of 128 eligible participants will be randomized in a 1:1 ratio to either the intervention or waitlist control group within each region (n = 32 per group per region). The intervention group will receive an eight-week NL-MBSR program delivered live via Zoom, incorporating guided mindfulness practices and gentle yoga under nurse facilitation. The waitlist control group will continue routine community health care during the study period and will be offered the intervention after completion of follow-up assessments.
Baseline assessments will include MENQOL, mindfulness (MAAS), and sexual function (FSFI), conducted after written informed consent. Reporting will adhere to CONSORT guidelines for non-pharmacological trials and align with SPIRIT 2025 protocol recommendations (Schulz et al., 2010; SPIRIT Initiative, 2025) (Table 1).
Revised SPIRIT 2025 Schedule (SPIRIT Initiative, 2025).
Abbreviations: STRAW+10 = Stages of Reproductive Aging Workshop; MENQOL = menopause-specific quality of life; MAAS = Mindful Attention and Awareness Scale; FSFI = Female Sexual Function Index.
Study Population
The study population will consist of early postmenopausal women residing in selected urban and rural areas of Gangtok district. Recruitment will occur through active community outreach in collaboration with ASHAs and local health centers to enhance representativeness and reduce self-selection bias. Potentially eligible women will be identified using community health records and preliminary age criteria. Final eligibility will be determined by menstrual history consistent with STRAW+10 early postmenopause criteria and review of predefined exclusion criteria.
Inclusion criteria require the ability to read and understand Nepali, Hindi, or English and access to a smartphone with stable internet connectivity for participation in Zoom-based sessions. Women with major sensory or communication impairments, current hormone therapy or hormonal contraceptive use, prior hysterectomy or oophorectomy, or serious medical or psychiatric illness will be excluded. Prior exposure to formal mindfulness or meditation training will be recorded and considered in exploratory analyses. Written informed consent will be obtained prior to enrolment. To achieve the required final sample, approximately 188 women will be approached and screened before randomization in a 1:1 ratio to intervention and waitlist control groups.
Intervention
The intervention is an eight-week NL-MBSR program tailored for early postmenopausal women. The curriculum is based on Kabat-Zinn's standardized MBSR framework (Kabat-Zinn, 1990) and adapted for community delivery in collaboration with a clinical psychologist.
The program will be delivered live via Zoom to enhance accessibility for both urban and rural participants. Core components include body scan meditation, mindful breathing, sitting meditation, mindful movement (gentle yoga), mindful eating, and attention-focused exercises. The intervention begins with a three-hour orientation session introducing mindfulness principles and providing guidance on digital platform use. Each subsequent week focuses on a structured thematic component, supported by guided practice and group reflection. Participants will be encouraged to engage in 30-minute home practice daily using guided materials.
Content Validity of the NL-MBSR Program. Prior to implementation, the adapted NL-MBSR curriculum will be reviewed by a panel of 5–7 experts, including a clinical psychologist, a menopause specialist, senior nursing faculty, and a mindfulness practitioner. Content validity will be assessed using Item-level and Scale-level Content Validity Index (I-CVI and S-CVI). An I-CVI ≥0.78 and an S-CVI ≥0.80 will be considered acceptable. Revisions will be incorporated prior to trial initiation. Facilitator Training and Cultural Adaptation. The intervention will be delivered by a registered nurse investigator trained in standardized mindfulness facilitation, including supervised practice and competency evaluation by a clinical psychologist to ensure adherence to the manualized protocol. The curriculum has been culturally adapted to enhance contextual relevance through the use of locally appropriate terminology, culturally familiar examples, and sensitivity to family responsibilities and discussions of menopausal concerns. Waitlist Control. Participants in the waitlist control group will continue routine community health services during the 8-week study period. Routine care refers to services provided through Urban Health Centers and Primary Health Sub-centers without structured mindfulness or behavioral stress-reduction programming. After completion of follow-up assessments, waitlist participants will be offered the full NL-MBSR program (Table 2). Adherence and Fidelity Monitoring. Adherence will be monitored through Zoom attendance logs and self-reported home practice diaries. Attendance of ≥75% of scheduled sessions will be considered adequate adherence. Adherence data will be analyzed descriptively as feasibility indicators and will not constitute primary or secondary outcomes (Figure 1).
CONSORT 2010 Flow Diagram for Randomized Waitlist-Controlled Trial.
Session Structure of Nurse-Led Mindfulness-Based Stress Reduction (NL-MBSR) Curriculum.
Intervention fidelity will be ensured through a standardized delivery manual, session-specific checklists, and independent spot-check review of selected sessions using a structured fidelity assessment tool. Attrition will be defined as formal withdrawal from the study or failure to complete the post-intervention assessment.
Randomization and Blinding
Participants will be randomly assigned to either the NL-MBSR intervention group or the waitlist control group in a 1:1 allocation ratio. Randomization will be stratified by residence (urban/rural) to ensure balanced representation across geographic settings. Separate computer-generated randomization sequences will be created for each stratum using random number generation software by an independent researcher not involved in recruitment, intervention delivery, outcome assessment, or data analysis.
Allocation concealment will be ensured using the Sequentially Numbered, Opaque, Sealed Envelope (SNOSE) technique. Envelopes will be prepared in advance according to the randomization sequence and will be opened sequentially only after completion of baseline assessment and confirmation of eligibility. Due to the behavioral nature of the intervention, participant blinding is not feasible. However, outcome assessments will be conducted by a trained research assistant who remains blinded to group allocation. Participants will be instructed not to disclose their group assignment during assessment procedures. The statistician will analyze de-identified datasets labeled only with study identification codes and will remain blinded to group allocation until completion of the primary analysis.
Role separation will be maintained throughout the trial. The nurse investigator will serve exclusively as intervention facilitator and will not be involved in eligibility screening, outcome data collection, data entry, or statistical analysis.
Study Outcomes
The primary outcome is the change in MENQOL total score from baseline to week 8 (MENQOL; Hilditch et al., 1996). Secondary outcomes include MAAS (Brown & Ryan, 2003) and FSFI (Rosen et al., 2000), and satisfaction scores.
Sample Size
The sample size was calculated based on the primary outcome of the trial, which is the change in MENQOL total score from baseline to week 8. In randomized controlled trials, it is methodologically appropriate to power the study based on a single clearly defined primary outcome to avoid multiplicity-related inflation and overestimation of required sample size.
The sample size was calculated a priori using G*Power software (Version 3.1.9.7, Heinrich-Heine-Universität Düsseldorf, Germany) for a two-group comparison of mean differences. The calculation was based on the primary outcome: between-group difference in MENQOL total score at 8 weeks. Based on findings from a prior randomized controlled trial evaluating MBSR among postmenopausal women (Yazdani Aliabadi et al., 2021), a moderate standardized effect size (Cohen's d = 0.60) was assumed.
The following parameters were specified in G*Power:
Statistical test: Means–Difference between two independent means (two groups) Tail(s): Two-tailed Effect size (d): 0.60 α error probability: 0.05 Power (1–β): 0.80 Allocation ratio (N2/N1): 1
The analysis indicated that 88 participants (44 per group) would be required to detect a statistically significant difference. To account for an anticipated attrition rate of up to 30% (based on digital behavioral intervention literature), the total sample size was inflated using standard attrition adjustment procedures:
Accordingly, the final target sample size was set at 128 participants (64 per group) to ensure adequate power after potential dropout. Approximately 188 women will be approached during community recruitment to achieve the required final sample following screening and consent procedures.
Outcome Measures
Validated tools are used to evaluate four key domains impacted in early postmenopause: quality of life, psychosocial regulation, physical symptoms, and sexual functioning. Evaluations will take place at baseline, weekly throughout the 8-week intervention, and at the post-intervention follow-up. Therefore, while conceptual overlap may exist at the experiential level, these instruments operationalize distinct constructs.
Quality of Life
MENQOL will be assessed using the MENQOL questionnaire (Hilditch et al., 1996), a 29-item instrument comprising four domains: vasomotor (items 1–3), psychosocial (items 4–10), physical (items 11–26), and sexual (items 27–29). Each symptom is rated on a 7-point Likert-type scale reflecting the degree of bother experienced. Total and domain scores will be calculated at baseline and week 8. Changes in the MENQOL total score constitute the primary outcome of the study. Weekly MENQOL assessments will be used to examine symptom trajectory during the intervention period.
Mindful Attention and Awareness
Mindfulness will be assessed using the MAAS (Brown & Ryan, 2003). The MAAS is a 15-item validated scale measuring dispositional mindful attention and awareness, defined as present-centered, non-judgmental awareness of ongoing experiences. Items are rated on a 6-point Likert scale, with higher scores indicating greater mindfulness. The MAAS assesses a psychological regulatory capacity rather than psychosocial symptom burden directly.
Sexual Function
Sexual functioning will be evaluated using the FSFI (Rosen et al., 2000), a 19-item validated instrument assessing six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Domain scores are computed using weighted item sums, and total scores range from 2 to 36, with lower scores indicating poorer sexual function. Unlike the MENQOL sexual domain, which reflects symptom-related impact on quality of life, the FSFI assesses functional aspects of sexual response. FSFI questionnaires will be self-administered in a private setting.
Satisfaction and Feasibility
Participant satisfaction with the NL-MBSR program will be assessed at week 8 using a 10-item structured satisfaction scale developed for this study. Items will evaluate perceived usefulness, clarity of instruction, digital accessibility, cultural relevance, and overall satisfaction using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores will range from 10 to 50, with higher scores indicating greater satisfaction. The satisfaction scale will be administered only to participants in the intervention group and analyzed descriptively.
To minimize participant burden, the estimated completion time for baseline assessments is ∼20–25 min. Weekly MENQOL administration requires ∼5–7 min. Participants will be permitted short breaks during questionnaire completion if needed. The selected instruments are validated for repeated administration and are commonly used in longitudinal menopausal research. Weekly MENQOL tracking is limited to a single instrument to monitor symptom trajectory while minimizing questionnaire fatigue. Strategies to reduce response burden include clear instructions, private self-administration, and supportive assistance when requested.
Tool Validity and Translation
The MENQOL, MAAS, and FSFI are well-established, and there is robust evidence supporting their psychometric properties in menopausal populations (Brown & Ryan, 2003; Hilditch et al., 1996; Rosen et al., 2000). Cronbach's alpha for MENQOL has been reported to vary from 0.82 to 0.93, for MAAS from 0.80 to 0.87, and for FSFI from 0.89 to 0.97. The instruments were translated into Nepali and Hindi using forward-backward translation procedures to ensure linguistic equivalence (World Health Organization, 2019).
This systematic strategy guarantees that these instruments are culturally relevant and enable the investigation of the effectiveness of the NL-MBSR intervention for early postmenopausal women (Table 3).
Description of Assessment Tools with Evidence of Validity and Reliability.
Abbreviations: MENQOL = menopause-specific quality of life; MAAS = Mindful Attention and Awareness Scale; FSFI = Female Sexual Function Index.
Trial Oversight and Data Management
Trial Oversight
The trial will be overseen by a Trial Oversight Committee comprising the Principal Investigator, one co-investigator with expertise in clinical research, and one independent nursing faculty member. The committee will monitor trial conduct, protocol adherence, participant safety, and data integrity. Given the minimal-risk nature of the intervention, a separate Data Safety Monitoring Board will not be constituted.
Data Management
Each participant will be assigned a unique study identification code at enrolment. All questionnaires and electronic datasets will contain only this code. A master linking log will be stored separately in a password-protected file accessible only to the Principal Investigator. Data entry personnel and the statistician will analyze de-identified datasets without access to identifying information.
Statistical Analysis
All statistical analyses will be conducted using IBM SPSS Statistics (Version 23.0; IBM Corp., 2015). Statistical significance will be set at a two-sided p-value < 0.05.
Analysis Population: Primary analyses will follow the intention-to-treat (ITT) principle, including all randomized participants in their allocated groups. A secondary per-protocol analysis will include participants attending ≥75% of scheduled sessions. Descriptive Analysis: Baseline characteristics will be summarized by group using mean ± SD or median (IQR) for continuous variables and frequencies (%) for categorical variables. Baseline comparability will be assessed using independent t-tests or Mann–Whitney U tests (continuous variables) and chi-square or Fisher's exact tests (categorical variables). Primary Outcome Analysis: The primary efficacy analysis will be a between-group comparison of post-intervention MENQOL scores using analysis of covariance (ANCOVA) adjusted for baseline MENQOL score and age, time since final menstrual period, and stratification variable (rural/urban residence). This approach improves statistical precision and controls for baseline imbalance.
Within-group pre-post comparisons will be conducted using paired t-tests as supportive analyses. MENQOL domain subscales (vasomotor, psychosocial, physical, and sexual) will be analyzed as secondary exploratory outcomes.
Secondary Outcome Analysis: Secondary outcomes include:
MAAS (mindful attention and awareness) FSFI (sexual function total score) Satisfaction score (post-intervention only)
Between-group comparisons at week 8 will be conducted using ANCOVA adjusted for baseline values (for MAAS and FSFI). Satisfaction scores will be summarized descriptively in the intervention group. Because the trial is powered for the primary outcome only, secondary outcome findings will be interpreted cautiously.
Between-group comparisons adjusted for baseline values will allow estimation of intervention effects independent of facilitator interaction, while stratified randomization and blinded analysis further reduce bias.
Repeated Measures Analysis: Weekly MENQOL scores will be analyzed using repeated measures ANOVA or linear mixed-effects models to assess symptom trajectory and group-by-time interaction. Multicollinearity Assessment: Prior to multivariable analyses, Pearson correlation coefficients will be examined among MENQOL subscales, MAAS, and FSFI scores. Variance Inflation Factors (VIFs) will be calculated to assess multicollinearity. A VIF>5 will be considered indicative of problematic collinearity. If necessary, analyses will be conducted using domain-specific models to maintain statistical independence. Exploratory Predictor Analysis: Exploratory regression models will examine predictors of change in MENQOL total score, including age, time since menopause, baseline severity, residence, education, marital status, digital literacy exposure, and prior mindfulness exposure.
Handling of Missing Data
Missing data patterns will be examined. If missingness is <5%, complete-case analysis will be performed. If ≥5%, multiple imputation under a missing-at-random assumption will be applied, with sensitivity analyses comparing imputed and non-imputed results. No interim analysis is planned due to the short duration and minimal-risk design.
Participant Information and Ethical Considerations
Participants will receive verbal and written study information in English, Hindi, or Nepali. The materials describe the study purpose, procedures, potential benefits, and possible risks (e.g. mild emotional discomfort or minor physical strain during gentle yoga). Participation will be voluntary, and women may withdraw at any time without affecting routine care. Written informed consent will be obtained prior to enrolment, including thumb impression where applicable, in accordance with Good Clinical Practice guidelines (International Council for Harmonisation, 2016).
Ethical approval has been obtained from the Institutional Ethics Committee, and the trial has been prospectively registered with the Clinical Trials Registry. The study will be conducted in accordance with the Declaration of Helsinki (World Medical Association, 2013). Any protocol amendments will be submitted to the Ethics Committee and updated in the trial registry.
Digital Confidentiality: Zoom sessions will be conducted using password-protected meetings with waiting-room control enabled via an institutional licensed account. Recording and auto-transcription functions will be disabled, and no session content will be stored. Participants will be advised to attend from a private space and use headphones where possible. Attendance logs will document session participation only and will not capture discussion content. Attendance records will be stored in password-protected institutional systems accessible only to authorized research team members.
A group confidentiality agreement will be signed prior to the first session. Participants will be reminded not to record, screenshot, or disclose personal identifiers. While reasonable safeguards will be implemented, participants will be informed that absolute online privacy cannot be guaranteed. FSFI questionnaires will be self-administered privately and will not be discussed during group sessions. Participants may request individual consultation if needed.
Harms and Safety Monitoring Procedures
All adverse events will be documented in a structured log, including severity, duration, relatedness, and action taken. Events will be reviewed biweekly by the Principal Investigator. Serious adverse events will be reported to the Institutional Ethics Committee within 24 h. Adverse events will be classified as mild, moderate, or severe. Participants experiencing moderate or severe events attributable to the intervention may discontinue participation following clinical and ethical review.
Bias and Mitigation Strategies
Performance bias: Participant blinding is not feasible due to the behavioral nature of the intervention. To reduce expectancy effects, participants in both groups will be informed that the study evaluates different approaches to menopausal well-being without emphasizing superiority.
Detection bias: Outcomes will be measured using validated instruments. Assessments will be conducted by a blinded research assistant, and participants will be instructed not to disclose group allocation. Statistical analyses will be performed on de-identified datasets by a blinded statistician.
Selection bias: Stratified randomization (urban/rural) and allocation concealment using the SNOSE technique will minimize baseline group imbalance.
Contamination bias: Waitlist participants will be requested not to initiate structured mindfulness or stress-reduction programs during the 8-week period. Self-initiated practices will be documented and considered in exploratory analyses.
Attrition bias: Primary analyses will follow the intention-to-treat principle. Missing data will be handled using multiple imputation where appropriate, with sensitivity analyses comparing imputed and complete-case results.
Facilitator expectancy bias: The intervention facilitator will not be involved in screening, outcome assessment, data entry, or statistical analysis. Intervention fidelity will be monitored using standardized session checklists and independent review of selected sessions.
Digital access bias: Participants will receive orientation to the digital platform prior to the first session, and technical support will be provided to minimize exclusion related to digital literacy.
Discussion
This randomized waitlist-controlled trial is designed to evaluate the effectiveness and feasibility of a nurse-led, digitally supported MBSR (NL-MBSR) program for women in early postmenopause. By focusing specifically on this stage of reproductive aging, the study addresses a population that remains relatively underrepresented in intervention research despite ongoing symptom burden during the early postmenopausal years.
The primary endpoint is the change in MENQOL total score. Quality of life in this study is operationalized through the MENQOL total score, which integrates vasomotor, psychosocial, physical, and sexual domains into a single multidimensional construct rather than treating these domains as independent primary outcomes. Secondary measures of mindfulness and sexual function are included to explore broader domains of psychosocial regulation and functional well-being that may be influenced by mindfulness practice.
Existing evidence supports the role of mindfulness-based interventions in reducing perceived stress and vasomotor symptom distress in midlife women. However, stage-specific trials focusing exclusively on early postmenopause remain limited. This study extends prior research by applying a standardized MBSR framework within a clearly defined reproductive stage using validated outcome measures and a controlled design.
A distinctive feature of this trial is the integration of synchronous digital delivery within a nurse-led model. Unlike fully automated applications, the intervention incorporates live facilitator guidance, structured interaction, and monitored practice. This approach seeks to balance accessibility with therapeutic engagement, potentially enhancing adherence and skill acquisition in community settings.
Methodological strengths include stratified randomization, allocation concealment, blinded outcome assessment, intention-to-treat analysis, predefined adherence criteria, and fidelity monitoring. These design elements enhance internal validity and reduce the risk of systematic bias.
Several limitations should be acknowledged. Participant blinding is not feasible due to the behavioral nature of the intervention, and outcomes rely on self-reported measures. The study is powered primarily for the MENQOL total score; secondary outcomes may be underpowered for detecting smaller effects. The eight-week duration limits conclusions to short-term outcomes, and the single-district setting may affect generalizability. Digital delivery may also pose challenges for participants with limited technological familiarity.
Despite these considerations, this trial evaluates a context-sensitive and potentially scalable model for integrating mindfulness-based strategies into nurse-led community care. If effective, the NL-MBSR program may represent a culturally adaptable, low-cost, non-pharmacological approach to supporting women during early postmenopause and inform future implementation and scale-up research.
Footnotes
Acknowledgements
The authors sincerely acknowledge the support of community health workers (ASHAs) and the participating women for their cooperation during the planning of this study. We also acknowledge the contribution of the clinical psychologist who provided expert input during the cultural adaptation of the mindfulness intervention. No professional writing or third-party editorial assistance was used in the preparation or submission of this manuscript.
Ethical Considerations
Ethical approval was obtained from the Institutional Ethics Committee, Sikkim Manipal Institute of Medical Sciences, Sikkim Manipal University, Sikkim, India (SMIMS/IEC/2025-02, dated 12-02-2025). The study complies with national and international ethical guidelines for research involving human participants. The trial is registered with the Clinical Trials Registry of India (CTRI/2025/04/084701). 
Consent to Participate
Written informed consent was obtained from all participants prior to enrolment. Participants were informed about the study objectives, procedures, the voluntary nature of participation, and their right to withdraw at any time without consequences.
Consent for Publication
Not applicable. This manuscript does not contain any identifiable individual data, images, or personal information requiring consent for publication.
Author Contributions
SRP conceived and developed the study protocol and prepared the initial draft of the manuscript. BK supervised study design and methodology, provided critical revisions, and BD supervised study design and methodology and serves as the corresponding author. SD contributed to the study design and advised on outcome measures, whereas SOL critically reviewed the manuscript. All authors read and approved the final version.
Funding
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study is entirely self-funded as part of the doctoral research of the first author. No external funding has been received. The authors affirm that all Article Processing Charges (APC), if applicable, will be fully covered by the researchers themselves. The ability to bear APC costs does not influence the study design or outcomes, and the authors assure the journal that payment of APCs will be completed promptly upon acceptance of the manuscript.
Declaration of Conflicting Interest
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Availability of Data and Materials
The datasets generated and analyzed during the current study are not publicly available as the trial is ongoing, but anonymized data will be available from the corresponding author on request after study completion.
Trial Status
Recruitment for the final study is expected to begin in April 2026 and is anticipated to be completed by May 2027.
Trial Registration
Additional Identifying Information
All author, institutional, funding, and ethics-related identifying information is provided exclusively on this Title Page and has been removed from the anonymized manuscript file to ensure blinded peer review.
Dissemination Plan
The results of the study will be published in peer-reviewed journals, presented at scientific meetings, and submitted to the Clinical Trials Registry. After completion of the study, a plain-language summary of the results will be provided to participants. No identifiable details will be disclosed in any publication or report.